title: Evaluation of the recombinant VlsE-based liaison chemiluminescence immunoassay for detection of Borrelia burgdorferi and diagnosis of Lyme disease.
abstract: Recent efforts to improve the serologic diagnosis of Lyme disease have included the use of a synthetic peptide (C6) that reproduces the sequence of invariable region 6 of VlsE, the variable surface antigen of Borrelia burgdorferi. In the present study, the diagnostic performance of DiaSorin's recombinant VlsE-based chemiluminescence immunoassay in 1,947 human serum samples was evaluated. Sensitivity was determined using two serum panels from the CDC. For panel I, we observed sensitivities of 68.4% and 75.6% for subjects with early, localized (n=19) or disseminated (n=41) disease, respectively. For panel II, we observed sensitivities of 61.5% and 100% for subjects with early (n=26) or late-stage (n=11) disease, respectively. We observed a specificity of 99.5% for healthy donors (n=600) living either in regions of the United States where the disease is endemic or in regions where it is not endemic. Overall, specificity among 207 potentially cross-reactive sera from subjects who had other spirochetal infections, nonspirochetal infections including bacterial and viral infections, or autoimmune or neurologic disease; who were positive for rheumatoid factor or anti-mouse antibodies; or who had been previously vaccinated for Lyme disease was 93.7%. In a direct comparison of 1,038 prospectively collected samples for Lyme disease testing we observed a relative sensitivity of 70%, a relative specificity of 99.1%, and an overall agreement of 97.1% between the DiaSorin recombinant VlsE chemiluminescence immunoassay and the Immunetics peptide-based C6 enzyme-linked immunosorbent assay.
authors.affiliation: Foundation for Blood Research, 8 Science Park Road, Scarborough, ME 04074, USA. tledue@fbr.org
authors.forename: Thomas B
authors.initials: TB
authors.lastname: Ledue
authors.forename: Marilyn F
authors.initials: MF
authors.lastname: Collins
authors.forename: John
authors.initials: J
authors.lastname: Young
authors.forename: Martin E
authors.initials: ME
authors.lastname: Schriefer
mesh_terms: D000328:Adult; D000907:Antibodies, Bacterial / Q000097:blood*; D000942:Antigens, Bacterial / Q000276:immunology*; D000954:Antigens, Surface / Q000276:immunology; D001425:Bacterial Outer Membrane Proteins / Q000276:immunology; D001426:Bacterial Proteins / Q000276:immunology*; D001428:Bacterial Vaccines / Q000276:immunology; D025065:Borrelia burgdorferi / Q000276:immunology / Q000302:isolation & purification*; D005260:Female; D006801:Humans; D007118:Immunoassay; D008074:Lipoproteins / Q000276:immunology*; D008163:Luminescent Measurements / Q000379:methods*; D008193:Lyme Disease / Q000175:diagnosis*; D022123:Lyme Disease Vaccines / Q000276:immunology; D008297:Male; D011446:Prospective Studies; D011994:Recombinant Proteins / Q000276:immunology; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
chemical_list: D000907:Antibodies, Bacterial; D000942:Antigens, Bacterial; D000954:Antigens, Surface; D001425:Bacterial Outer Membrane Proteins; D001426:Bacterial Proteins; D001428:Bacterial Vaccines; D008074:Lipoproteins; D022123:Lyme Disease Vaccines; C072045:OspA protein; D011994:Recombinant Proteins; C105546:VlsE protein, Borrelia burgdorferi